Job Description
2 years of relevant experience or in a similar environment
Excellent documentation, computer literacy in MS word
Perform primary and secondary GMP packaging operations in strict accordance with approved batch records, cGMPs, SOPs, and safety regulations
Accurately complete all required GMP documentation to ensure contemporaneous and compliant records of equipment use and packaging activities
Handle, move, and package clinical trial materials while fully adhering to safety, quality, and regulatory requirements
Use the approved inventory system (CAIS) to scan materials and execute packaging-related tasks
Support routine daily, weekly, monthly, and quarterly cleaning and maintenance of GMP packaging rooms and equipment
Follow production schedules and timelines while assisting with resolution of common equipment or process issues
Comply with all gowning, hygiene, and cleanroom requirements, including restrictions on makeup, jewelry, and personal items
Meet physical and cognitive demands of the role, including prolonged standing, lifting up to 45 lbs, and sustained mental, visual, and manual attention
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
A client of Insight Global is looking to onboard several Packaging and Labeling Technicians in Groton, CT. The Packaging and Labelling Technician role must maintain daily compliance to Standard Operating Procedures (SOPs), in accordance with current Good Manufacturing Practice (cGMP) guidelines and is responsible for performing operations to support the packaging and labelling of clinical trial supplies. The Technician role performs both Primary Packaging and Secondary Packaging Operations. This may include (but is not limited to): solid dose drug product by way of manual hand count filling into bottles or by use of minor equipment for automated filling, packaging finished dosage forms such as filled bottles, ointments, pre-filled vials and labelling of other pre-packaged finished material. This position is also responsible to maintain the packaging equipment for daily use including cleaning.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.